# The role of the enrolling clinician in emergency research conducted under an exception from informed consent

## TL;DR

This paper argues that clinicians should have more say in emergency research by using informed consent exceptions on a per-patient basis.

## Contribution

A novel ethical justification for using EFIC per patient, emphasizing the clinician's role in enrollment decisions.

## Key findings

- Applying EFIC per study leads to ethical controversy due to lack of individual patient consideration.
- Enrolling clinicians' judgment per patient strengthens the ethical foundation of emergency research.
- Involving clinicians in enrollment decisions can reduce controversy and improve research ethics.

## Abstract

The Exception from Informed Consent (EFIC) permits patient enrolment into therapeutic emergency research where obtaining informed consent is challenging. Yet this fails to resolve a core ethical conflict in the research and has generated controversy. This is because existing justification and practice has relied on applying EFIC per study—a wholesale permission to enroll irrespective of circumstance—instead of per patient. Our novel justification for enrolment centers on applying EFIC per patient, which empowers the enrolling clinician to judge whether to enroll patients with an Exception. This contrasts with the idea that clinician judgment is surplus to the judgements already made by institutions in deciding the research may proceed. Instead, we show that enrolling clinician’s judgment is ethically significant and should not be overlooked: attending to this strengthens the research ethically and reduces controversy. There should be a bigger role for the clinician in the research enrolment space.